Bioelectrical signal processing application software - ARTG 476310
Access comprehensive regulatory information for Bioelectrical signal processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476310 and sponsored by Natus Medical Pty Ltd, manufactured by Micromed SPA in Italy. The device registration started on January 21, 2025.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
BRAIN QUICK Software is intended to acquire scalp and intracranial electroencephalographic (EEG) signals and polysomnographic (PSG) signals. It is also able to drive a cortical stimulator and monitor other physiological measurements coming from third-party interfaced medical devices. Electroencephalography and Polysomnography consist in the recording of electrical activity of the brain, together with other physiological parameters, and they can be used for neurophysiological studies and analysis, as diagnostic aid for the evaluation of disturbances of the functions of the Central Nervous System. When a cortical stimulator is used, the software can be also be used as help in the preliminary or intraoperative localization of the intervention sites for epilepsy surgery (stereoEEG). In order to display and analyze the recorded signals, the software must work in combination with Micromed SD devices. The software does not make any judgment of normality or abnormality from displayed signals or the result of an analysis. None of the functions of the software are considered in themselves diagnostic